AMLODIPINE CINFA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

amlodipine cinfa 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is amlodipine cinfa and what is it used for
2. What you need to know before you take amlodipine cinfa
3. How to take amlodipine cinfa
4. Possible side effects
5. Storage of amlodipine cinfa
6. Contents of the pack and other information

1. What is amlodipine cinfa and what is it used for

amlodipine cinfa contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

amlodipine cinfa is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare form called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, amlodipine cinfa improves blood supply to the heart muscle, which receives more oxygen and as a result, the pain in the chest is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take amlodipine cinfa

Do not take amlodipine cinfa

• If you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. This may cause itching, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipine cinfa.

You should inform your doctor if you have or have had any of the following diseases.

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are an elderly person and your dose needs to be increased

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipine should only be used to treat high blood pressure in children and adolescents from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Other medicines and amlodipine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Amlodipine may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
• simvastatin (a medicine that lowers cholesterol)
• cyclosporin (an immunosuppressant)

If you are already taking other medicines to treat high blood pressure, amlodipine may lower your blood pressure even further.

Taking amlodipine cinfa with food and drinks

People taking amlodipine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of amlodipine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, inform your doctor before taking amlodipine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or cause you headaches, do not drive or use machinery and consult your doctor immediately.

amlodipine cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take amlodipine cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 5 mg of amlodipine, once a day. The dose can be increased to 10 mg of amlodipine, once a day.

You can take this medicine before or after meals. It should be taken at the same time each day, with a glass of water. Do not take amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Currently, amlodipine 2.5 mg is not available and the dose of 2.5 mg cannot be obtained with the amlodipine cinfa 5 mg tablets since these tablets are not designed to be divided into equal parts. The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more amlodipine cinfa than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty and you could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take amlodipine cinfa

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking amlodipine cinfa

Your doctor will indicate how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Go to your doctor immediatelyif you experience any of the following side effects after taking this medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort.

The following side effect has been reported very frequently. If this causes problems or lasts more than a week, consult your doctor.

Very common (may affect more than 1 in 10 patients)

• Edema (fluid retention)

The following side effects have been reported frequently. If any of these cause problems or last more than a week, consult your doctor.

Frequent (may affect up to 1 in 10 patients)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Alteration of bowel habits, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon (may affect up to 1 in 100 patients)

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Pain in the muscles or joints, back pain
• Weight gain or loss

Rare (may affect up to 1 in 1,000 patients)

• Confusion

Very rare (may affect up to 1 in 10,000 patients)

• Decrease in the number of white blood cells, decrease in blood platelets that can cause easy bleeding or unusual bruising
• Excess sugar in the blood (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes that can have an effect on some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Frequency not known (cannot be estimated from the available data)

• Tremors, rigid posture, mask-like face, slow and unbalanced movements

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of amlodipine cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of amlodipine cinfa

• The active substance is amlodipine besylate. Each tablet contains amlodipine besylate equivalent to 5 mg of amlodipine.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (type A) (potato), and magnesium stearate.

Appearance of amlodipine cinfa and contents of the pack

amlodipine cinfa are white, uncoated tablets, scored on one side and engraved with "5" on the other. They are available in PVC/Al blisters in packs of 28, 30, or 500 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

Manufacturer(s)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

or

Adamed Pharma, S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Date of last revision of this leaflet:July 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65460/P_65460.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65460/P_65460.html